Status:
COMPLETED
PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Macromastia
Eligibility:
FEMALE
20-60 years
Phase:
NA
Brief Summary
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events a...
Detailed Description
Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue from both female breasts for therapeutic or cosmetic indications. The purpose of the breast reduction is to ...
Eligibility Criteria
Inclusion
- Age between 20 and 60
- Physically healthy, stable weight, non-smoker
- Desiring bilateral breast reduction
- Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
- Subject must be willing and able to comply with specified follow-up evaluations.
- Female subjects must either be no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.
Exclusion
- Age younger than 20 or greater than 60 years old
- Anticoagulation therapy which cannot be discontinued
- Smoking (any kind)
- Infection (local or systemic)
- Cognitive impairment or mental illness
- Severe cardiopulmonary deficiencies
- Known coagulopathy
- Immunocompromised
- Prior history of breast cancer
- Kidney disease (any type)
- Currently taking any medication known to affect healing
- Subjects who are status-post gastric banding or gastric bypass
- Currently enrolled in another investigational device or drug trial
- Unable to follow instructions or complete follow-up
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00986453
Start Date
January 1 2010
End Date
September 1 2011
Last Update
January 1 2013
Active Locations (7)
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1
Providence St. Joseph's
Burbank, California, United States, 91505
2
Verdugo Hills Hospital
Glendale, California, United States, 91218
3
El Camino Hospital
Mountain View, California, United States, 94040
4
Tri-City Medical Center
Oceanside, California, United States, 92056